Concept
Biomarker qualification is the process by which a biomarker is rigorously evaluated and accepted for a specific context of use in drug development and regulatory decision-making. This ensures that the biomarker is reliable, reproducible, and relevant for its intended purpose, ultimately aiding in drug development and patient care.
Relevant Degrees
Concept
Biomarker validation is a critical process in ensuring that a biomarker is accurately and reliably associated with a clinical outcome or biological condition. It involves rigorous testing and analysis to confirm the biomarker's specificity, sensitivity, and reproducibility across different populations and settings.
3